data analyses for ancillary wise femhrt hormone replacement study

Conditions: Myocardial Ischemia

Summary: the goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive cad. for the purposes of this study as a core lab coordinating center, the investigators will be performing p31 mrs core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and homa core lab analyses; exercise stress test/holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. the main trial duration: december 1999 - may 2003. the ancillary data analysis project duration: april 2006 - march 2010.

see brief summary above.

Eligibility criteria:
inclusion criteria * postmenopausal wise and nonwise study participants * normal/minimally diseased coronary arteries (\<50% luminal diameter stenosis in all epicardial coronary arteries) within 36 months of ancillary study entry and no intercurrent mi, ptca, cabg * any one (or multiple) of the following criteria suggestive of myocardial ischemia within 36 months of ancillary study entry: 1. abnormal p-31 magnetic resonance spectroscopy (a fall in quantitative pcr/atp ratio \>15% from control) performed at a wise or nonwise site 2. positive exercise stress test (\> or = 1mm horizontal or downsloping, or \> or =1.5mm upsloping st segment depression measured 0.08 msec after the j point), performed and/or interpretated by a wise or wise ancillary ancillary trial investigator 3. reversible stress radionuclide perfusion defect \> equivocal and not attributable to breast/imaging artifact. performed as part of the wise protocol 4. coronary artery flow reserve \<2.25 performed. as part of using the wise protocol * no contraindications to 12 weeks of femhrt or hormone replacement therapy * normal mammogram and pelvic exam (including pap smear for those with an intact uterus) within 12 months of study entry * documented normal liver function testing (sgot) within 3 months of study entry. exclusion criteria * documented myocardial infarction, coronary artery bypass surgery or mechanical revascularization * systolic blood pressure \>200 mmhg or diastolic blood pressure \>105 mmhg * ldl-cholesterol \>190 mg/dl, triglycerides \> or = 300 mg/dl * clinically significant hepatic or renal dysfunction (sgot more than 1.2 times normal at baseline, serum creatinine \>2) * uncontrolled diabetes mellitus (fbs \> or = 225 mg/dl) or new onset diabetes until stabilized * clinically significant valvular heart disease, dilated cardiomyopathy, or congestive heart failure (nyha class iv or severe class iii) * currently on hormone replacement therapy and unwilling/unable to withdraw treatment prior to study, (participants are eligible for study entry 4-8 weeks following hormone replacement therapy withdrawal, at the discretion of the wise ancillary trial principal investigator) * previous breast cancer, mammogram suggestive of cancer, or endometrial cancer without hysterectomy * abnormal uterine bleeding or abnormal pap smear (sil i, ii or iii, carcinoma in situ, or cancer) * previous deep venous thrombosis, pulmonary embolism, or other thromboembolic disorder. * alcoholism or drug abuse * participation in any other investigational drug or device study women with elevated diastolic (\> or = 90 mm hg) or systolic (\> or = 140 mm hg) blood pressure, ldl-cholesterol (\> or = 160 mg/dl), fasting blood sugar (\> or = 130 mg/dl) and women who smoke cigarettes will be told their risk factor levels and referred for evaluation and treatment by their private physician.